Kornimate/medical-research-clean huggingface dataset:
role of t follicular helper cells in autoimmune hemolytic anemia (tfh in aiha)

Conditions: Autoimmune Hemolytic Anemia

Summary: t follicular helper (tfh) cells represent a t cell subset dedicated to the activation of b cells. they have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and sjögren disease. we recently showed that tfh are implicated in the activation of autoreactive b lymphocytes during itp. autoimmune hemolytic anemia (aiha) is an autoimmune disease due to antibodies targeting red blood cells. to date, the role of tfh in the pathogenesis of aiha is not known. we hypothesize that aiha is associated with an increase in the number and/or function of tfh, that could participate in the activation of autoreactive b lymphocytes.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of warm aiha defined by * hemoglobin \<11 g/dl * low haptoglobin level * positive direct antiglobulin test (igg or igg + complement) * reticulocyte count \>120 g/l * patients * naive to treatment for hemolytic anemia or a in relapse * older than 18 years * able to understand written and spoken french * persons who have provided written consent control population * patients who have given consent * patients over 18 years * patients with cold agglutinin disease (progressive aiha and different treatments of warm autoantibody aiha) can be included as a sub-group of controls * patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,...) can be included as a sub-group of controls exclusion criteria: * patients without national health insurance * pregnancy or breast-feeding women * adults under guardianship * patients with cancer or malignant hemopathy * patients with an on-going infection * patients treated with corticoids or immunosuppressants
relationship of lumbopelvic musculature with functional tests in non-professional athletes with lumbar disc herniation

Conditions: Low Back Pain; Herniated Lumbar Disk; Sciatica

Summary: this is a control-case study. it has been designed to determine if there is a relationship between the cross sectional (thickness), through rusi ultrasound, of the abdominal muscles, lumbar and hip muscles with the results of the functional tests, to determine its relevance in patients with low back pain and / or ciatalgia and lumbar disc herniation in non-professional athletes. the secondary objectives of the study will be to know if there is a relationship between the results of ultrasound measurements and functional tests with the result of the disability questionnaires, the amount of pain and its location, as well as determine the relevance, depending on the results of ultrasound measurements and test of the presence or not of a lumbar disc herniation.


Eligibility criteria:
inclusion criteria: * age 18 to 55 years of age. * sports practice equal to greater than three hours per week. * no low back pain or ciatalgia in the last 12 months. exclusion criteria: * traumatic process or surgery in the lower back or lower limb in the last year. * alterations of the skin or local infection in the area to be examined or that impedes the ultrasonographic measurement or performance of the functional tests. * peripheral or central neurological pathology. * psychiatric pathology and / or cognitive alterations. * inflammatory and tumor diseases. * alterations that prevent the understanding of the indications and / or the performance of the tests. group selection criteria: * group 1(group without low back pain): no low back pain or ciatalgia in the last 12 months. * group 2 (low back pain group): history of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using mri.

Keywords: ultrasound functional test herniated lumbar disk low back pain
investigation of efficacy and safety of epogam

Conditions: Atopic Dermatitis; Neurodermatitis

Summary: in this study it will be investigated if patients with atopic dermatitis responding to epogam treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.

patients with atopic dermatitis will receive epogam 1000 for 12 weeks. clinical symptoms of the disease will be assessed using the scorad score. dihomo-gamma-linolic acid levels in the blood will be measured with gc-ms.

Eligibility criteria:
inclusion criteria: * atopic dermatitis since at least 2 months (criteria after hanifin and rajka, 1980) * men or women aged 2 - 45 years * women of childbearing age using contraception * informed consent of the patient or of the parents exclusion criteria: * psychiatric disorder * abuse of drugs or alcohol * chronic dermatosis * glaucoma, cataract or ocular herpes simplex * immune deficiency * immunological diseases * clinical relevant changes in laboratory parameters * congenital diseases * scabies, infections with dermathophytae, hiv-associated dermatosis * malignant diseases * metabolic diseases * parasites * patients enrolled in other studies * progredient, systemic diseases * pregnancy and lactation * severe internistic diseases * organ transplantation in the medical history * hypersensitivity against an ingredient of the study medication
elastography and treatment of lymphoma

Conditions: Elastography; Lymphoma

Summary: to determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.

lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation of lymphocytes. it represents approximately 5% of malignancies. overall survival is estimated to be 72%. (1) lymphomas are broadly classified into hodgkin lymphoma (hl) (10%) and non-hodgkin lymphoma (nhl) (90%). hl is further classified into classical and non-classical types and nhl into b-cell, t-cell and natural killer (nk) cell types. diagnosis of lymphoma is confirmed by histopathology (fnac, true-cut or excisional biopsy).(2) the standard treatment of lymphoma is chemotherapy and radiotherapy. the modalities used for staging and follow up of lymphoma are: * computed tomography (ct) chest, abdomen and pelvis. * positron emission tomography (pet/ct). * whole body magnetic resonance imaging (mri).(3) sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. it may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. to the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.(4)

Eligibility criteria:
inclusion criteria: * patients who are histopathologically proven as lymphoma, not receive treatment and have superficial lymphadenopathy. exclusion criteria: * 1-lymphoma without superficial lymph nodes. 2-patients under treatment.
long term safety and efficacy of biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in oceania and north america. the aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the biasp-1234 trial.


Eligibility criteria:
inclusion criteria: * subjects must have been correctly included in and completed biasp-1234 exclusion criteria: * persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial * fulfilment of any withdrawal criteria prior to and including the final visit of the biasp-1234. * females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,iud (intra uterine device), oral contraceptives or barrier methods) * known or suspected allergy to trial product or related products * development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the investigator indicates a progressed state of disease
comparison of a paper and automated bladder diary in pediatric patients

Conditions: Lower Urinary Tract Symptoms; Voiding Disorders; Enuresis; Overactive Bladder

Summary: the purpose of this study is to compare an automated bladder diary (autobd) to a paper bladder diary (pbd) on their level of agreement, patient compliance and satisfaction. it is a mixed methods, randomized 2x2 crossover trial. pediatric patients (6 to 12 years) presenting to the clinic and identified as requiring a bladder diary will be recruited. participants will be randomized either to group 1, where they complete the paper bladder diary (pbd) and then the automated bladder diary (autobd), or to group 2, where they complete the autobd and then the pbd. both diaries are kept for at least 2 consecutive days with a wash-out period of 2 to 6 days between the two diaries. mean differences and the level of agreement between the pbd and autobd will be analysed using bland altman plots for key diary parameters. after completion of each diary format, participants will complete a short online survey regarding compliance, satisfaction and their preference, if any. finally, a selection of participants and their parents will be invited for an open-ended interview. the participating healthcare professionals will be asked to score each pbd and autobd on patient compliance when processing the diary. furthermore, surveys and open-ended interviews will be conducted to assess their overall satisfaction of each diary type and their preference, if any.

for some time now, patient compliance with paper bladder diaries is being questioned. paper bladder diaries are often incomplete, unreliable and/or of low quality. multiple electronic bladder diaries have been developed to overcome some of the limitations associated with paper bladder diaries. however, based on several comparison studies between paper and electronic bladder diaries, it is not clear whether an electronic format alone is truly superior to the paper format. the investigators want to introduce and evaluate the feasibility of a new type of bladder diary: an automated bladder diary. in contrast to an electronic diary, an automated diary automatically registers voiding data using a connected measuring device. an electronic diary simply eliminates the use of paper, but the patient still needs to measure the voided volumes with a urinary container and manually enter them in the electronic diary. the investigators believe an automated diary may lead to improved patient compliance by reducing the required efforts from the patient and instead provide guidance and prompts.

Eligibility criteria:
inclusion criteria: * pediatric patients presenting to the clinic and identified as requiring a bladder diary * age: 6 to 12 years * sex: male or female * child and/or parent own and are able to operate a smartphone and/or tablet exclusion criteria: * change in urologic treatment during the data collection period * inability to hold the diary pod while urinating * inability to speak, read and write dutch
effects of imagery and breathing exercises on swimmers' performance, mental toughness, and heart-mind coherence

Conditions: Athletic Performance; Mental Toughness; Coherence (Heart-Mind Synchronization)

Summary: this randomized controlled trial aimed to investigate the effects of a 10-week imagery and breathing exercise intervention on 200-meter freestyle swimming performance, mental toughness, and heart-mind coherence in swimmers. nineteen licensed swimmers aged 13-18 years were randomly assigned to an experimental group (n=9) receiving imagery and breathing exercises or a control group (n=10) receiving only standard physical training. outcomes were measured using the 200-meter freestyle swimming time, the sports mental toughness questionnaire (smtq), and heart-mind coherence via the inner balance heartmath device. the intervention significantly improved mental toughness and swimming performance in the experimental group compared to the control group, with a trend toward improved heart-mind coherence.

the study was conducted at the facilities of pamukkale üniversitesi mensupları spor kulübü yüzme takımı in denizli, türkiye. participants underwent a pre-test/post-test design with the following measures: 200-meter freestyle swimming performance, mental toughness (assessed via the sports mental toughness questionnaire), and heart-mind coherence (measured using the inner balance heartmath device for real-time biofeedback of heart rate variability \[hrv\]). the experimental group participated in a 10-week intervention involving daily imagery and breathing exercises performed before bedtime, following a structured protocol (4-second inhale through the nose, 4-second exhale through the mouth, while imagining a 200-meter swim with detailed visualization). the intervention included a 6-day training period on techniques, followed by 10 weeks of daily practice, with reminders and feedback provided via a whatsapp group. the control group continued standard physical training without additional mental training. data were analyzed using a two-way repeated measures anova, with post-hoc bonferroni tests, and a significance level of p\<0.05.

Eligibility criteria:
inclusion criteria: * aged 13-18 years. * licensed and actively engaged in competitive swimming. * no serious injuries in the past 6 months. * parental consent obtained for participants under 18 years. exclusion criteria: * diagnosis of heart disease or respiratory system disorders. * psychiatric diagnosis or ongoing psychological treatment. * serious injury or surgery within the past 6 months.

Keywords: swimming imagery mental toughness coherence heart rate variability breathing exercises sports psychology athletic performance mental training
efficacy and safety of alt-801 in the treatment of obesity

Conditions: Obesity/Overweight

Summary: this study will evaluate the efficacy and safety of alt-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.


Eligibility criteria:
inclusion criteria: * written informed consent signed prior to entry into the study * male or female age 18 to 75 years, inclusive * body mass index (bmi) ≥ 30 kg/m2 or bmi ≥ 27 kg/m2 combined with at least one obesity-related comorbidity * at least one unsuccessful weight loss attempt per investigator judgement * agreement to comply with the study-required life-style intervention and treatment during the full duration of the study * female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control exclusion criteria: * weight gain or loss \> 5% in the 3 months prior to randomization or \>10% in the 6 months prior to screening * diabetes and related conditions: 1. history or clinical evidence of diabetes mellitus of any type, including type 1, type 2, or mature onset diabetes of the young (mody) 2. hba1c \> 6.5%, fasting glucose ≥ 126 mg/dl (6.9 mmol/l), and/or random glucose of ≥ 200 mg/dl (11.0mmol/l) at screening * obesity and related conditions: 1. obesity induced by known genetic causes or endocrine disorders (eg, cushing syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone \[tsh\] \> 6 miu/l) 2. history of bariatric surgery or other surgical treatment for obesity (eg, gastric banding, gastric bypass), or planned surgery or surgical treatment during the study. liposuction and/or abdominoplasty performed \>1 year before screening is allowed. endoscopically placed intragastric balloons will be allowed if removed \> 1 year before screening. * gastrointestinal conditions: 1. history of acute or chronic pancreatitis within 1 year (365 days) before screening 2. history of or acute significant gastrointestinal (gi) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease \[gerd\], 3. history of gi surgery, including cholecystectomy and antrectomy. surgery for appendicitis and small bowel resection \>20cm is acceptable. 4. history of inflammatory bowel disease, celiac disease or any medical condition or surgery that could affect gastric emptying, stool frequency or stool consistency. (irritable bowel syndrome is permitted provided that bowel frequency and consistency are normal off treatment.) * mental health conditions: 1. untreated depressive disorder, defined as a patient health questionaire-9 (phq-9) score of ≥ 15 at screening 2. suicide ideation, defined as type 4 or 5 on the columbia-suicide severity rating scale(c-ssrs) at screening, lifelong history of a suicide attempt, or suicidal behavior within 30 days before screening 3. other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
efficacy and safety of rimonabant on weight loss and frequency of binge episodes in obese patients

Conditions: Obesity; Eating Disorders

Summary: the primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder. the secondary objectives are: * to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the binge eating scale (bes) and three factor eating questionnaire (tfeq), * to evaluate the safety and tolerability of rimonabant over a period of 6 months.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥30 to ≤45 kg/m² * diagnosis of eating disorder using the questionnaire on eating and weight patterns (qewp-r) for diagnosing eating behaviors exclusion criteria: * history of surgical procedures for weight loss * treatment with anti-obesity drugs within 3 months prior to screening visit * presence or history of diagnostic and statistical manual of mental disorders (4th edition)(dsm iv) bulimia or anorexia nervosa the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: binge eating eating disorders obesity
nirs monitoring during intracranial interventions

Conditions: Subarachnoid Hemorrhage; Intracranial Arteriovenous Malformation

Summary: near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during intracranial interventions. however, it yields artificial results when the dye indocyanine green (icg) is applied, which is routinely done for intraoperative angiography. the investigators examine, to what extent and which duration nirs is disturbed following icg application.


Eligibility criteria:
inclusion criteria: * patients scheduled for aneurysm clipping or av-malformation removal exclusion criteria: * pregnancy
avoid delivering therapies for non-sustained arrhythmias in icd patients iii

Conditions: Heart Disease

Summary: to demonstrate a reduction in the number of ventricular therapies (atp and shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (cl≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of r-r intervals necessary to detect ventricular events.

primary objective: the primary objective is to demonstrate a 20% reduction of ventricular therapies (atp and shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (cl ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (nid) compared to a nid of 18 out of 24 in subjects with either class i or iia indication for icd implantation, regardless of cardiac resynchronization capabilities. secondary objectives: 1. evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (cl ≤ 320 ms) and for spontaneous ventricular episodes. 2. evaluate the efficacy of atp in successfully treating spontaneous ventricular episodes (cl: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study. 3. evaluate acceleration rate or degeneration into vf of spontaneous episodes (cl of 200ms-320ms) due to atp therapy in the two study arms. 4. compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (cl ≤ 320 ms). 5. describe the economic impact and the quality of life consequences.

Eligibility criteria:
inclusion criteria: * either icd or crt+icd indications (class i-iia) according to the current aha / acc / esc guidelines. * previous implant of a medtronic device including "atp during charging" feature for 15 days at the maximum. exclusion criteria: * icd replacements and upgrading. * brugada syndrome, long qt and hcm patients * ventricular tachyarrhythmia associated with reversible cause. * other electrical implantable devices (neurostimulators, etc.). * subject's life expectancy less than 1 year. * subject on heart transplant list which is expected in less than 1 year. * subject is \<18 years of age, or the subject is under a minimum age that is required as defined by local law * women who are pregnant or women of childbearing potential who are not on a reliable form of birth control. * unwillingness or inability to provide written informed consent. * enrolment in, or intention to participate in, another clinical trial. * inaccessibility to come to the study center for the follow-up visits. * mechanical tricuspid valve.

Keywords: implantable cardiac defibrillator therapies reduction shocks quality of life